Dronedarone Impurity 92 CAS 141626-35-9

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.141626-35-9
Molecular FormulaC27H36N2O5S
Molecular Weight500.65 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 92 CAS 141626-35-9 chemical structure

Description

CATO supplies Dronedarone Impurity 92 (CAS 141626-35-9), a pharmacopoeial impurity reference standard (molecular formula C27H36N2O5S, MW 500.65 g/mol) used for the identification and quantification of trace impurities in APIs.

Dronedarone Impurity 92 (C27H36N2O5S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Dronedarone Impurity 92 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC27H36N2O5S
Molecular Weight500.65 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Nitrogen Atoms2
Sulfur Atoms1

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